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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031907
Receipt No. R000036429
Scientific Title A confirmatory study examining effects of continuous intake of test food on healthy adults
Date of disclosure of the study information 2018/03/26
Last modified on 2018/11/29

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Basic information
Public title A confirmatory study examining effects of continuous intake of test food on healthy adults
Acronym A confirmatory study examining effects of continuous intake of test food on healthy adults
Scientific Title A confirmatory study examining effects of continuous intake of test food on healthy adults
Scientific Title:Acronym A confirmatory study examining effects of continuous intake of test food on healthy adults
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effects on muscle mass, bone density, cognitive function, body composition, and QOL in postmenopausal women aged 50 to 69 after 24 weeks of continuous intake of test food.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes muscle mass, bone density
Key secondary outcomes Markers in blood (osteocalcin, TRACP-5b, BDNF, FSH, LH, estrone, HDL-C, LDL-C, TC, and TG) and urine (deoxypyridinoline), scores of Cognitrax, vital signs, QOL questionnaire (SF-36, bowel habit questionnaire)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Take 4 capsules of test food t.i.d.
Interventions/Control_2 Take 4 capsules of placebo t.i.d.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit
69 years-old >=
Gender Female
Key inclusion criteria 1.Age:50 to 69 years old
2.Gender:Women
3.Healthy adults (We define "healthy adults" as those who currently have neither severe organ damage nor a particular disease, who currently do not receive treatment associated with those disorders, and who currently do not receive any kind of drug treatment. We judge whether or not a candidate meets this definition according to the self-report submitted when a clinical trial is commenced)
4.Postmenopausal women
5.Those who can give their written informed consent
Key exclusion criteria 1.Those who currently receive continuous drug treatment (except for drugs that are taken as needed)
2.Those who currently undergo dietary or exercise therapy under the direction of physicians
3.Those with a past medical history of any of the following: hepatic disease, severe disorder (kidney, endocrine, cardiovascular, gastrointestinal, and lung diseases, and blood and metabolic disorders), or complications
4.Those with a past medical history of mental disorder (such as depression)
5.Those with a past and current medical history of drug or food allergy
6.Those who work night shifts or irregular shifts
7.Those who currently take health food and supplements (except for those who can stop taking them after they have signed an informed consent form)
8.Smokers
9.Those who currently take warfarin product (such as Warfarin, Warlin, Arefarin, Warfarin K, etc.)
10.Those who have metallic orthopedic implants
11.Those who underwent barium enema in 3 days before the commencement of this clinical trial
12.Those who have done fingernail or toenail designs on the day of a bone density test
13.Those who are participating in other clinical trials or participated in the past 1 month and then took their test products
14.Any other conditions, in the opinion of the principal investigator, those who were determined to be unsuitable for participation in this clinical trial
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Nakamura
Organization Higashi Koganei Sakura Clinic
Division name Chairman
Zip code
Address 4-37-26,Higashicho,Koganei-shi,Tokyo,Japan
TEL 042-382-3081
Email higashikoganeisakura-clinic@imeq.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naomi Yuzawa
Organization imeQ co.Ltd
Division name Sales department
Zip code
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo, Japan
TEL 03-6225-6222
Homepage URL
Email n-yuzawa@imeq.co.jp

Sponsor
Institute imeQ co.Ltd
Institute
Department

Funding Source
Organization euglena Co.Ltd
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 26 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036429

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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